Early InterventionsNCT03013023
Effects of Early Behavioral and Transaction Interventions on Preterm Infants' and Parents' Biopsychosocial Well-being
A study testing BS, Routine care and PITP in people with Early Interventions and Preterm Infants, run by National Defense Medical Center, Taiwan.
Trial summary
This randomized controlled trial will use a longitudinal repeated-measures design to examine the effects of two interventions, behavioral support interventions and a parent-infant transactional program, on parents' stress, PPD and sleep quality, parent-infant interactions, and their preterm infants' stress (saliva… Read more about this study
- Who is it for?
- Ages 28 weeks to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Early Interventions, Preterm Infants, Parent-Child Relations
- What is being tested?
- BS, Routine care and PITP
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Apr 2015to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 28 weeks to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Gestational age (GA) > 28 weeks and < 37 weeks
- Postbirth age >2 days
- Stable condition (score<20 on the Neonatal Therapeutic Intervention Scoring System [NTISS] for disease severity).
- Parents are not diagnosed with mental illness or some other illness known to influence/confound the outcome variables
- Parents are fluent in Chinese
- Parents do not use drugs
- Parents agree to participate in this study
Who cannot join
- Congenital anomalies
- Neurologic impairment including convulsion, intraventricular hemorrhage > grade II or periventricular leukomalacia
- Documented congenital or nosocomial (infection acquired at hospital after birth) sepsis
- Surgery
- Severe medical conditions requiring treatments such as cortisol supplementation, sedatives, muscle relaxants, antiepileptic, or analgesic drugs
About this study
Official title: Early Behavioral and Transaction Interventions on Preterm Infants' and Parents' Biopsychosocial Well-being
This randomized controlled trial will use a longitudinal repeated-measures design to examine the effects of two interventions, behavioral support interventions and a parent-infant transactional program, on parents' stress, PPD and sleep quality, parent-infant interactions, and their preterm infants' stress (saliva cortisol levels), sleep patterns, emotional regulation, and neurobehavioral developmental outcomes from 7 days to 2 years corrected age.
Read the detailed description
The proposed study has five specific aims:
- to develop behavioral-support interventions for preterm infants who receive painful, stressful procedures in the NICU,
- to develop a parent-infant transactional program (PITP) for parent-infant dyads with preterm infants in the NICU,
- to determine the short-term effects of the behavioral-support interventions and PITP on infant stress (salivary cortisol levels) and sleep patterns,
- to determine the short-term effects of the PITP on parental stress, depression, social support, and sleep quality during postpartum, and
- to determine the long-term effects of the behavioral-support interventions and PITP on parent-infant interactions and infants' long-term emotional regulation and neurobehavioral outcomes.
- Conditions
- Early Interventions, Preterm Infants, Parent-Child Relations
- Being tested
- BS, Routine care, PITP, BS+PITP
- Keywords
- Behavioral and Transaction Interventions, Parents' Biopsychosocial Well-being, Preterm Infants, Sleep, Salivary cortisol
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BSBehavioural
NNS, FT, positional support, and oral sucrose feeding
Routine careBehavioural
Routine NICU care
PITPBehavioural
Parents will learn to regulate infant responses while implementing caregiving activities.
BS+PITPBehavioural
Parents will learn to regulate infant responses while implementing caregiving activities. Supportive interventions, i.e., NNS, FT, positional support, and oral sucrose feeding, will be provided while infants are undergoing painful procedures.
| Study group | Role | What they receive |
|---|---|---|
| Routine care | Placebo comparator | Control group Receives: Behavioral: Routine care |
| Behavioral-support interventions (BS) | Active comparator | NNS, FT, positional support, and oral sucrose feeding will be provided while infants are undergoing painful procedures Receives: Behavioral: BS |
| Parent-infant transaction program (PITP) | Active comparator | The PITP will be a six-session, one-on-one teaching intervention beginning on day 22 after birth, with four sessions at bedside, and two home-visit sessions within the first month after discharge. Receives: Behavioral: PITP |
| BS+PITP | Active comparator | Behavioral-support interventions + Parent-infant transaction program Receives: Behavioral: BS+PITP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parent stress
Accessed by Parenting Stress Index-Short form (PSI-SF)
Measured: 7days to 12 months
Parent depression
Accessed by the Edinburgh Postnatal Depression Scale (EPDS)
Measured: 7days to 12 months
Parent sleep
Accessed by Pittsburgh Sleep Quality Index
Measured: 7days to 12 months
Parent social support
Accessed by the Social Support Rating Scale (SSRS)
Measured: 7days to 12 months
Secondary outcomes (3)
Parent-infant interaction
Assessed by NCASTfeeding scale
Measured: 1 month to 6 months
Preterm infant's sleep
Assessed by Actigraphy
Measured: up to 3 months
Preterm infant's stress
Assessed by Salivary cortisol
Measured: up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study startApr 2015
- Primary completionMar 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early InterventionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Defense Medical Center, Taiwan
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Responsible party
- Principal investigator, Hsiang-Yun Lan, National Defense Medical Center, Taiwan
- Investigators
- Jen-Jiuan Liaw, Professor, Study chair, Professor, School of Nursing, National Defense Medical Center, Taipei, Taiwan, ROC.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03013023
- Sponsor's protocol ID
- 1-103-05-165
- Status last verified
- Oct 2020
- First submitted
- 29 Dec 2016
- Last updated
- 3 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Behavioral and Transaction Interventions on Preterm Infants' and Parents' Biopsychosocial Well-being
- ClinicalTrials.gov ID
- NCT03013023
- Acronym / sponsor ID
- 1-103-05-165
- Conditions
- Early Interventions, Preterm Infants, Parent-Child Relations
- Keywords
- Behavioral and Transaction Interventions, Parents' Biopsychosocial Well-being, Preterm Infants, Sleep, Salivary cortisol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Defense Medical Center, TaiwanUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Study start
- Apr 2015
- Primary completion
- Mar 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 6 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled trial will use a longitudinal repeated-measures design to examine the effects of two interventions, behavioral support interventions and a parent-infant transactional program, on parents' stress, PPD and sleep quality, parent-infant interactions, and their preterm infants' stress (saliva cortisol levels), sleep patterns, emotional regulation, and neurobehavioral developmental outcomes from 7 days to 2 years corrected age.
Detailed description
The proposed study has five specific aims:
- to develop behavioral-support interventions for preterm infants who receive painful, stressful procedures in the NICU,
- to develop a parent-infant transactional program (PITP) for parent-infant dyads with preterm infants in the NICU,
- to determine the short-term effects of the behavioral-support interventions and PITP on infant stress (salivary cortisol levels) and sleep patterns,
- to determine the short-term effects of the PITP on parental stress, depression, social support, and sleep quality during postpartum, and
- to determine the long-term effects of the behavioral-support interventions and PITP on parent-infant interactions and infants' long-term emotional regulation and neurobehavioral outcomes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Routine care | Placebo comparator | Behavioral: Routine careControl group |
| Behavioral-support interventions (BS) | Active comparator | Behavioral: BSNNS, FT, positional support, and oral sucrose feeding will be provided while infants are undergoing painful procedures |
| Parent-infant transaction program (PITP) | Active comparator | Behavioral: PITPThe PITP will be a six-session, one-on-one teaching intervention beginning on day 22 after birth, with four sessions at bedside, and two home-visit sessions within the first month after discharge. |
| BS+PITP | Active comparator | Behavioral: BS+PITPBehavioral-support interventions + Parent-infant transaction program |
Who may qualify
- Ages
- 28 weeks to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Gestational age (GA) > 28 weeks and < 37 weeks
- Postbirth age >2 days
- Stable condition (score<20 on the Neonatal Therapeutic Intervention Scoring System [NTISS] for disease severity).
- Parents are not diagnosed with mental illness or some other illness known to influence/confound the outcome variables
- Parents are fluent in Chinese
Key exclusion criteria (5 listed)
- Congenital anomalies
- Neurologic impairment including convulsion, intraventricular hemorrhage > grade II or periventricular leukomalacia
- Documented congenital or nosocomial (infection acquired at hospital after birth) sepsis
- Surgery
- Severe medical conditions requiring treatments such as cortisol supplementation, sedatives, muscle relaxants, antiepileptic, or analgesic drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BSNNS, FT, positional support, and oral sucrose feeding | Behavioural | Behavioral-support interventions (BS) |
| Routine careRoutine NICU care | Behavioural | Routine care |
| PITPParents will learn to regulate infant responses while implementing caregiving activities. | Behavioural | Parent-infant transaction program (PITP) |
| BS+PITPParents will learn to regulate infant responses while implementing caregiving activities. Supportive interventions, i.e., NNS, FT, positional support, and oral sucrose feeding, will be provided while infants are undergoing painful procedures. | Behavioural | BS+PITP |
Primary outcome
Parent stress
Time frame: 7days to 12 months
Accessed by Parenting Stress Index-Short form (PSI-SF)
Parent depression
Time frame: 7days to 12 months
Accessed by the Edinburgh Postnatal Depression Scale (EPDS)
Parent sleep
Time frame: 7days to 12 months
Accessed by Pittsburgh Sleep Quality Index
Parent social support
Time frame: 7days to 12 months
Accessed by the Social Support Rating Scale (SSRS)
3 secondary outcomes
Parent-infant interaction
Time frame: 1 month to 6 months
Preterm infant's sleep
Time frame: up to 3 months
Preterm infant's stress
Time frame: up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jen-Jiuan Liaw, Professor study chair
Professor, School of Nursing, National Defense Medical Center, Taipei, Taiwan, ROC.
Questions about this trial
What is this clinical trial studying?
A study testing BS, Routine care and PITP in people with Early Interventions and Preterm Infants, run by National Defense Medical Center, Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parent stress (time frame: 7days to 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2020.